UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030062 |
|---|---|
| Receipt number | R000031891 |
| Scientific Title | A multi-center, cluster randomized controlled study comparing usual care and a multidisciplinary intervention such as the DELirium Team Approach program to manage delirium among hospitalized cancer patients |
| Date of disclosure of the study information | 2017/12/11 |
| Last modified on | 2019/06/07 11:22:00 |
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Basic information
Public title
A multi-center, cluster randomized controlled study comparing usual care and a multidisciplinary intervention such as the DELirium Team Approach program to manage delirium among hospitalized cancer patients
Acronym
DELTA study
Scientific Title
A multi-center, cluster randomized controlled study comparing usual care and a multidisciplinary intervention such as the DELirium Team Approach program to manage delirium among hospitalized cancer patients
Scientific Title:Acronym
DELTA study
Region
| Japan |
Condition
Condition
Malignacy
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology | Geriatrics | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Chest surgery | Breast surgery |
| Nursing | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Delirium, defined as an acute disorder of attention and global cognitive function, is a common, serious, and potentially preventable cause of morbidity and mortality in hospitalized older persons. Primary prevention - preventing delirium before it develops - is the most effective strategy for reducing the incidence of this condition. The purpose of this multicenter, cluster randomized controlled study is to evaluate the effectiveness of multidisciplinary intervention in preventing the development of delirium and minimizing its severity in hospitalized cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence in events in medical safety such as falls, self-removal of drip infusion or drain tube, restraint
Key secondary outcomes
Falls, Self-removal of drip infusion or drain tube, Restraint, Barthel Index, Level of nursing care needs, Antipsychotic drug use, Opioid use, Duration of hospital stay, Cost of medical care, Hospital readmission within 1 month after discharge, Mortality within 1 year after discharge
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Implementation of the DELTA program with six components: (1) education of health care providers, (2) screening of delirium, (3) planning for delirium care, (4) prevention of occurrence and worsening of delirium, (5) scheduled assessment of delirium symptoms or risk factors, and (6) management and treatment of delirium.
Interventions/Control_2
Usual care
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Diagnosis of cancer at the primary site in health insurance claims
(2) Age >= 50
(3) Hospitalized patients in eligible wards
(4) Expected to live for more than 1 month
(5) Ability to communicate and write in Japanese
(6) Obtained informed consent from the patient or legally acceptable representative
Key exclusion criteria
(1) Discharge within 24 hours after admission
(2) Severe mental disorder
(3) Patients incapable of completing this study as determined by the primary physician or investigator
(4) Expected to live for less than 1 month
(5) Readmission within length of registration
Target sample size
9600
Research contact person
Name of lead principal investigator
| 1st name | Asao |
| Middle name | |
| Last name | Ogawa |
Organization
National Cancer Center
Division name
Division of Psycho-Oncology, Exploratory Oncology Research&Clinical Trial Center
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577 Japan
TEL
04-7134-7013
asogawa@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Kanno |
| Middle name | |
| Last name | Yusuke |
Organization
National Cancer Center
Division name
Division of Psycho-Oncology, Exploratory Oncology Research&Clinical Trial Center
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577 Japan
TEL
04-7134-7013
Homepage URL
ykanno@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
The Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577 Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東札幌病院(北海道）、手稲渓仁会病院（北海道）、石巻赤十字病院（宮城県）、仙台医療センター（宮城県）、宮城県立がんセンター（宮城県）、がん・感染症センター都立駒込病院（東京都）、国立国際医療研究センター（東京都）、千葉医療センター（千葉県）、市立豊中病院（大阪府）、近畿中央胸部疾患センター（大阪府）、彩都友紘会病院（大阪府）、関西医科大学病院（大阪府）、和泉市立病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
9600
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 21 | Day |
Last modified on
| 2019 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031891
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/10/03 | DELTA study（UMIN登録用20191002）.xlsx |
